NL-OMON49947招募中不适用
Platelet-activation and optimal inhibition in patients with Atrial Fibrillation undergoing LAA closure; The POPULAR-LAAO trial - POPULAR-LAAO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- The subject is aged 18 years or older
- •- The subject is accepted/scheduled for left atrial appendage closure
- •- The subject has a CHA*DS*-VASc Score >=2 (male) or >=3 (female)
- •- The subject or legal representative is able to understand and is willing to
- •provide written informed consent to participate in the trial.
排除标准
- •- Unable or unwilling to return for required follow-up visits and examinations
- •- Mechanical heart valves or valvular disease requiring surgery or
- •interventional procedure
- •- Ongoing major bleeding or complicated or recent (<72hours) major surgery
- •- Known large oesophageal varices or decompensated liver disease (unless a
- •documented positive opinion of a gastro-enterologist)
- •- Severe thrombocytopenia (<50,000/ml)
- •- High likelihood of being unavailable for follow-up or psycho-social condition
- •making study participation impractical.
- •- Woman with child bearing potential who do not use an efficient method of
- •contraception.
- •- Positive serum or urine pregnancy test for woman with child bearing potential
- •- Pregnancy or within 48 hours post-partum
- •- unsuitable LAA anatomy for closure or thrombus in the LAA at the time of
- •- contraindications or unfavourable conditions to perform cardiac
- •catheterization or TEE
- •- atrial septal malformations, atrial septal defect or a high-risk patient
- •foramen ovale that may cause thrombo-embolic events
- •- atrial septal defect repair or closure device or a patent foramen ovale
- •repair or any other anatomical condition as this may preclude an LAAO procedure
- •- Mitral valve regurgitation grade 3 or more
- •- Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 mmHg) or regurgitation grade 3
- •- Planned CEA for significant carotid artery disease
- •- Life expectancy of less than 1 year
研究者
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